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Confocal Optical Imaging
FDA product code OWN · Class 2 · Gastroenterology, Urology
231
Registered devices
1,630
Adverse events
4
Recalls
63
510(k) clearances
Devices with this code
View4SurgN — Smartsurgn Inc.Open Field Fluorescence Imaging Head — Guangdong Optomedic Technologies, Inc.VS3-IR — VISIONSENSE LTD.AlveoFlex™ N — MAUNA KEA TECHNOLOGIESActiv Sight C-Mount Imaging Module — Activ Surgical, Inc.VS3 — VISIONSENSE LTD.CranioFlex™-C — MAUNA KEA TECHNOLOGIESConfocal Microprobe Imaging System — Wuxi Hisky Medical Technologies Co.,Ltd.NA — SCHÖLLY FIBEROPTIC GmbHNA — SCHÖLLY FIBEROPTIC GmbHVISERA ELITE III VIDEO SYSTEM CENTER — OLYMPUS MEDICAL SYSTEMS CORP.NA — SCHÖLLY FIBEROPTIC GmbHIMAGE 1 S — Karl Storz GmbH & Co. KGVS3-IR — VISIONSENSE LTD.UroFlex™B — MAUNA KEA TECHNOLOGIESVS3-IR — VISIONSENSE LTD.VS3 — VISIONSENSE LTD.VS3 Iridium — VISIONSENSE LTD.AlveoFlex™ — MAUNA KEA TECHNOLOGIESEleVision™ — SCHÖLLY FIBEROPTIC GmbHSterile Sheath for CONVIVO — Carl Zeiss Meditec AGVS3-IR — VISIONSENSE LTD.NA — SCHÖLLY FIBEROPTIC GmbHCystoFlex™F — MAUNA KEA TECHNOLOGIES
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-24 | Olympus Corporation of the Americas | Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure |
| 2022-10-17 | Visionsense, Ltd. | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. |
| 2022-10-17 | Visionsense, Ltd. | XXX |
| 2022-10-17 | Visionsense, Ltd. | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. |
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